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Anticancer cytotoxic agents go through a process by which their antitumor activity-on the basis of the amount of tumor shrinkage they could generate-has been investigated. In the late 1970s, the International Union Against Cancer and the World Health Organization introduced specific criteria for the codification of tumor response evaluation. In 1994, several organizations involved in clinical research combined forces to tackle the review of these criteria on the basis of the experience and knowledge acquired since then. After several years of intensive discussions, a new set of guidelines is ready that will supersede the former criteria. In parallel to this initiative, one of the participating groups developed a model by which response rates could be derived from unidimensional measurement of tumor lesions instead of the usual bidimensional approach. This new concept has been largely validated by the Response Evaluation Criteria in Solid Tumors Group and integrated into the present guidelines. This special article also provides some philosophic background to clarify the various purposes of response evaluation. It proposes a model by which a combined assessment of all existing lesions, characterized by target lesions (to be measured) and nontarget lesions, is used to extrapolate an overall response to treatment. Methods of assessing tumor lesions are better codified, briefly within the guidelines and in more detail in Appendix I. All other aspects of response evaluation have been discussed, reviewed, and amended whenever appropriate.

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Tumours respond differently to immunotherapies compared with chemotherapeutic drugs, raising questions about the assessment of changes in tumour burden—a mainstay of evaluation of cancer therapeutics that provides key information about objective response and disease progression. A consensus guideline—iRECIST—was developed by the RECIST working group for the use of modified Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) in cancer immunotherapy trials, to ensure consistent design and data collection, facilitate the ongoing collection of trial data, and ultimate validation of the guideline. This guideline describes a standard approach to solid tumour measurements and definitions for objective change in tumour size for use in trials in which an immunotherapy is used. Additionally, it defines the minimum datapoints required from future trials and those currently in development to facilitate the compilation of a data warehouse to use to later validate iRECIST. An unprecedented number of trials have been done, initiated, or are planned to test new immune modulators for cancer therapy using a variety of modified response criteria. This guideline will allow consistent conduct, interpretation, and analysis of trials of immunotherapies.

The Response Evaluation Criteria in Solid Tumors (RECIST) were developed and published in 2000, based on the original World Health Organization (WHO) guidelines first published in 1981. In 2009, revisions were made (RECIST 1.1) incorporating major changes, including a reduction in the number of lesions to be assessed, a new measurement method to classify lymph nodes as pathologic or normal, the clarification of the requirement to confirm a complete response (CR) or partial response (PR) and new methodologies for more appropriate measurement of disease progression. The purpose of this paper is to summarize the questions posed and the clarifications provided as an update to the 2009 publication.

As compared with placebo, letrozole therapy after the completion of standard tamoxifen treatment significantly improves disease-free survival.

The 70-gene signature adds independent prognostic information to clinicopathologic risk assessment for patients with early breast cancer.

P r o g n o s t i c F a c t o r s f o r S u r v i v a l i n A d u l t P a t i e n t s W i t h C e r e b r a l L o w -G r a d e G l i o m aPurpose: To identify prognostic factors for survival in adult patients with cerebral low-grade glioma (LGG), to derive a prognostic scoring system, and to validate results using an independent data set.Patients and Methods: European Organization for Research and Treatment of Cancer (EORTC) trial 22844 and EORTC trial 22845 are the largest phase III trials ever carried out in adult patients with LGG. The trials were designed to investigate the dosage and timing of postoperative radiotherapy in LGG. Cox analysis was performed on 322 patients from EORTC trial 22844 (construction set), and the results were validated on 288 patients from trial 22845 (validation set). Patients with pilocytic astrocytomas were excluded from this prognostic factor analysis.Results: Multivariate analysis on the construction set showed that age > 40 years, astrocytoma histology subtype, largest diameter of the tumor > 6 cm, tumor crossing the midline, and presence of neurologic deficit before surgery were unfavorable prognostic factors for survival. The total number of unfavorable factors present can be used to determine the prognostic score. Presence of up to two of these factors identifies the lowrisk group, whereas a higher score identifies high-risk patients. The validity of the multivariate model and of the scoring system was confirmed in the validation set.Conclusion: In adult patients with LGG, older age, astrocytoma histology, presence of neurologic deficits before surgery, largest tumor diameter, and tumor crossing the midline were important prognostic factors for survival. These factors can be used to identify lowrisk and high-risk patients. L OW-GRADE GLIOMAS (LGGs) are in general relatively slow-growing primary brain tumors, but they have a very heterogeneous clinical behavior. Many patients present with seizures only and remain stable for a prolonged period of time, whereas others present with functional deficits or signs of increased intracranial pressure that necessitate prompt surgical treatment. The best treatment policy for these tumors is still unclear. Some physicians advocate early and extensive surgery or early radiation therapy, 1-3 whereas others tend to postpone treatment until functional deficits are present. [1][2][3][4] Several studies have attempted to identify prognostic factors in LGG. 1,[5][6][7][8][9][10][11][12] Prognostic factors have various applications that could be of particular value in the heterogeneous population of LGG. This includes guidance for stratification in phase III trials and ultimately for treatment in individual patients. However, except for age, the importance of other prognostic factors for survival in LGG remains a matter of debate, and the need for validated prognostic factors has not been resolved. A number of patient and tumor characteristics, such as age at diagnosis, performance status, histology subtype, primary tumor classification (T clas...